Clinical Research Specialist, Senior

School of Medicine

Established in 1930, Duke University School of Medicine is the youngest of the nation's top medical schools. Ranked sixth among medical schools in the nation, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where interdisciplinary collaboration is embraced and great ideas accelerate translation of fundamental scientific discoveries to improve human health locally and around the globe. Composed of more than 2,600 faculty physicians and researchers, nearly 2,000 students, and more than 6,200 staff, the Duke University School of Medicine along with the Duke University School of Nursing, and Duke University Health System comprise Duke Health, a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Health Integrated Practice, Duke Primary Care, Duke Home Care and Hospice, Duke Health and Wellness, and multiple affiliations.

Occupational Summary

Perform a variety of research, data, and clerical duties of a routine and technical nature to support the conduct of clinical research for the Duke Cancer Institute’s [DCI] Bone Marrow Transplant Hematology Malignancies &Cellular Therapy Clinical Research Programs. Participate in day-to-day operations related to the collection, compilation, and documentation of clinical research data. The Oncology Clinical Research Unit [CRU] oversees the conduct of research.

Work Preformed

Operations, Study and Site Management –15% Effort

Recognizes when typical agreements (MTAs, CDAs, DUAs, DTAs, etc.) are necessary and alerts appropriate parties. Prepares for and provides support for study monitoring and audit visits, including support for the reviewer. Addresses and corrects findings. May train others. Maintains participant level documentation for all studies, including those that are complex in nature (e.g., procedural and interventional studies) and/or require access to the Duke EHR. May train or oversee others. Follows SOPs. Assists with maintenance of study level documentation. Participates in study team meetings.

Prepares for, coordinates, and actively participates in site visits. Communicates effectively with sponsors and/or CROs. Records basic protocol information in clinical research management system. Ensure that studies are conducted in compliance with institutional requirements and other policies. Follows protocol-specific systems and process flows. As directed, assists in preparing studies for closeout, (e.g., packing files, documenting files for storage, shipping extra supplies back to sponsor).

Communication –10% of Effort

Write and speak clearly in a variety of settings and styles to convey messages and ideas effectively. Respond to routine questions related to study protocol and refer more complex questions or escalate issues to others as appropriate.

Communicate and coordinate with other study personnel as required for study implementation and routine problem resolution.

Data –65% of Effort

Enters and collects data. Develops data entry or collection SOPs or tools. May provide oversight or training to study team members collecting or entering data. Assists with quality control and data cleaning as directed. Independently responds to queries created by a CRO or the data manager. Ensures accuracy and completeness of data for all studies, including those that are complex in nature. Recognizes data quality trends and escalates as appropriate. May develop tools for, and train others in, data quality assurance procedures. Follows required processes, policies, and systems to ensure data security and provenance. Follows predetermined SOPs to assist in documenting and maintaining documentation to facilitated data sharing. Knowledgeable about the use of data standard policies. Innovatively uses technology to enhance a research process. May train others. Assists in updating reports on study progress for the PI and other study team members and collaborators.

Leadership – 5% Effort

Maintains Duke and project specific training requirements. Keeps current with research updates by attending key external departmental meetings (i.e. Research Wednesday, RPN, additional training, etc.). Navigates processes and people involved in Duke clinical research, demonstrates the organizational awareness, and has the interpersonal skills necessary to get work done efficiently. Demonstrates resilience and is adaptive to change. Communicates effectively with others, regardless of reporting relationship, to accomplish shared work objectives.

Ethics –5% of Effort

Under supervision may collect information about AEs, identified in the protocol or investigator brochure. Prepares and submits documents needed for regulatory and safety reporting to sponsors and other agencies. May train or oversee others.

Type of Research:
This position is for a data coordinator within the multiple myeloma team.

And other work as assigned. The above statements describe the general nature and level of work being performed. This is not intended to be an exhaustive list of all responsibilities and duties required. Employees may be directed to perform job-related tasks other than those specifically presented in this description.

Minimum Qualifications

Education

Work requires an Associate's degree. Bachelor's Degree is strongly preferred.

Experience

One year of relevant experience. A Bachelor's degree may substitute for required experience. The preferred candidate will have oncology or research experience, training, education

Job Code: 00000803 CLINICAL RESEARCH SPECIALIST, SR
Job Level: 09

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